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About CMDRD
Issuance date
2016
2015
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before2008
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Main Enabling Legislation
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Medical Device Inventory
Regulations
2015
Administrative-Supervision
Measures for Unannounced Inspection of Drugs and Medical Devices (CFDA Order No.14 2015)
2015
Classification
Rules for Classification of Medical Devices (CFDA Order No.15 2015)
2015
Use
Administrative Measures for Quality Supervision on the Use of Medical Devices (CFDA Order No.18 2015)
2015
Registration
Naming Rules for Medical Device Generic Name (CFDA Order No.19 2015)
2015
Clinical-Verification
Technical Guideline for Clinical Evaluation of Medical Devices (CFDA notice No. 14, 2015)
2015
Registration
Technical Review Guiding Principles of Registration for Antibody Reagent and Detection Kit of Estrogen Receptor and Progestrone Receptor
2015
Manufacture
The guide on supplier audit for Medical Device Manufacturing Enterprise(CFDA Announcement No.1 2015)
2015
Registration
Principle for Dividing for the Registered Units of In Vitro Diagnostic Product (Exposure Draft) (Seek for opinions)
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